Label: BENZ PROTECT- benzoin resin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 27, 2017

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  • Active Ingredient

    Benzoin Compound Tincture (Benzoin, Aloe, Storax, Tolu, Balsam, Alcohol)

  • Intended Use

    • Forms a coating over a wound
    • For protecting recurring canker sores
  • Directions

    For adults and supervised children 2 years and older:
    Dry affected area of skin or oral mucosa. Apply with a cotton
    swab or gauze every 3-4 hours or as directed by your physician.

  • Warnings

    Do not

    • Use this product for more than 7 days unless directed by a dentist or doctor
    • Exceed recommended dosage

  • Stop use and ask a dentist or doctor if

    • Sore mouth symptoms do not improve in 7 days
    • Irritation, pain, or redness persists or worsens
    • Swelling, rash, or fever develop
  • Directions

    Adults and children 6 months or age and older: Dry affected area of oral mucosa. Apply the swab applicator every 3-4 hours or as directed by physician. Children under 6 months of age: Consult a dentist or Doctor

  • STORAGE AND HANDLING

    Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Avoid exposure
    to direct sunlight or heat.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of accidental ingestions, seek professional assistance or contact a Poison Control Center immediately

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BENZ PROTECT 
    benzoin resin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)  
    TOLU BALSAM (UNII: TD2LE91MBE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-099-103 mL in 1 POUCH; Type 0: Not a Combination Product10/27/2017
    2NDC:54162-099-50150 mL in 1 BOX; Type 0: Not a Combination Product10/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2015
    Labeler - Geritrex LLC (112796248)
    Registrant - Geritrex LLC (112796248)
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